– Monjuvi® U.S. net product sales of US$ 23.6
million (€ 20.5 million) for the fourth quarter and US$ 79.1
million (€ 66.9 million) for the full year 2021
– Pipeline advances: enrollment progressing
across three Phase 3 trials in myelofibrosis, first-line DLBCL, and
FL/MZL
– Results of the ongoing MANIFEST Phase 2 study
of pelabresib in combination with ruxolitinib for myelofibrosis
suggest potential benefit and disease modifying characteristics of
pelabresib
– € 976.9 million in cash and other financial
assets at December 31, 2021
Conference call and webcast (in English)
tomorrow, March 17, 2022, at 1:00pm CET (12pm GMT/8:00am EDT)
MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the
fourth quarter and full year 2021.
"In 2021, we accelerated our vision to become a leader in
hematology/oncology with the acquisition of Constellation
Pharmaceuticals which expanded our late-stage pipeline," said
Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We
are proud that approximately 2,000 patients have been treated with
Monjuvi in the U.S. since launch and continue to have the leading
market share of second line new patient starts."
Jean-Paul Kress continued, “Looking ahead, we are focused on
continued execution of the Monjuvi commercialization and rapidly
progressing our pivotal studies of pelabresib in myelofibrosis and
tafasitamab in 1L DLBCL, FL, and MZL. We are committed to bringing
innovative medicines to people with cancer and are well positioned
to deliver on our growth strategy to create long-term shareholder
value.”
Tafasitamab Highlights:
Monjuvi (tafasitamab-cxix) U.S. net product sales of €
20.5 million (US$ 23.6 million) for the fourth quarter of 2021 and
€ 66.9 million (US$ 79.1 million) for the full year of 2021.
Minjuvi® Royalty revenue of € 0.6 million for sales
outside of the U.S. in the fourth quarter of 2021. Full year 2021
Minjuvi royalty revenue of € 0.7 million.
Enrollment of first patient in Phase 3 trial evaluating the
safety and efficacy of tafasitamab compared to placebo in
combination with lenalidomide and rituximab in patients with
relapsed or refractory follicular lymphoma (FL) or marginal zone
lymphoma (MZL). In January 2021, FDA granted orphan drug
designation to tafasitamab for the treatment of follicular lymphoma
(FL), and the first patient was dosed in the phase 3 inMIND study
in April 2021.
Enrollment of first patient in Phase 3 trial evaluating
tafasitamab and lenalidomide in addition to R-CHOP in first-line
DLBCL patients. In May 2021, the first patient was dosed in the
pivotal Phase 3 frontMIND study evaluating tafasitamab and
lenalidomide in addition to rituximab, cyclophosphamide,
doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP
alone as first-line treatment for high-intermediate and high-risk
patients with untreated diffuse large B-cell lymphoma (DLBCL).
Health Canada and European Commission approve Minjuvi in
combination with lenalidomide for DLBCL. In August 2021, Health
Canada granted conditional marketing authorization for Minjuvi
(tafasitamab) in combination with lenalidomide for the treatment of
adults with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL) not otherwise specified, including DLBCL arising from low
grade lymphoma, who are not eligible for autologous stem cell
transplant (ASCT) and the European Commission granted conditional
marketing authorization for Minjuvi (tafasitamab) in combination
with lenalidomide, followed by Minjuvi monotherapy, for the
treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) who are not eligible for autologous
stem cell transplant (ASCT).
Announcement of real-world evidence for tafasitamab in
combination with lenalidomide for patients with DLBCL. In
December 2021, MorphoSys presented additional real-world evidence
results from the RE-MIND2 study comparing tafasitamab in
combination with lenalidomide against the most frequently used
treatments in adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL). These treatments include polatuzumab
vedotin plus bendamustine and rituximab (Pola-BR), rituximab plus
lenalidomide (R2), and CD19 chimeric antigen receptor T-cell
(CAR-T) therapies. The data was presented at the 63rd American
Society of Hematology Annual Meeting and Exposition (ASH 2021).
National Comprehensive Cancer Network® updates guidelines for
Monjuvi. On March 15, 2022, the National Comprehensive Cancer
Network updated the designation of Monjuvi (tafasitamab-cxix) to
preferred regimen in its Clinical Practice Guidelines in oncology
for B-cell Lymphomas.
Pelabresib Highlights:
Announcement of data from Phase 2 MANIFEST study in patients
with myelofibrosis. In December 2021, MorphoSys presented the
latest data from the ongoing MANIFEST study, an open-label, Phase 2
clinical trial of pelabresib, an investigational BET inhibitor, in
patients with myelofibrosis, a rare bone marrow cancer for which
only limited treatment options are available. The data confirm and
corroborate previously reported data, including updated data for
the primary endpoint spleen volume reduction at week 24 for the
combination arm 3 with ruxolitinib in frontline myelofibrosis and a
reduction in total symptom score. The data increased MorphoSys'
confidence in the probability of success for the phase 3 MANIFEST-2
study. These findings were presented at the 63rd American Society
of Hematology Annual Meeting and Exposition (ASH 2021).
Other Program
Highlights:
Enrollment of first patient in felzartamab Phase 2 trial for
Immunoglobulin A Nephropathy (IgAN). In October 2021, the first
patient has been dosed in the Phase 2 IGNAZ clinical trial
evaluating felzartamab for patients with (IgAN).
Announcement of first data from felzartamab Phase 1b/2a
study. In November 2021, MorphoSys presented interim results
from M-PLACE, the ongoing Phase 1b/2a, proof of concept study with
felzartamab in patients with membranous nephropathy (MN) at the
2021 Annual Meeting of the American Society of Nephrology
(ASN).
Corporate Updates:
MorphoSys acquires Constellation Pharmaceuticals. In June
2021, MorphoSys entered into a definitive agreement to acquire
Constellation Pharmaceuticals with its late-stage product candidate
Pelabresib (CPI 0610) for treating myelofibrosis and CPI-0209, a
mid-stage EZH2 inhibitor, for treating both hematologic and solid
tumors.
MorphoSys enters into funding agreement with Royalty
Pharma. MorphoSys secured from Royalty Pharma a US$ 1.425
billion upfront payment, access to Development Funding Bonds up to
US$ 350 million, and up to US$ 150 million in milestone payments.
As part of the agreement, Royalty Pharma Investments 2019 ICAV, a
subsidiary of Royalty Pharma plc, purchased US$ 100 million in
shares (1,337,552 shares) of MorphoSys at a price of € 63.35 per
share on July 16, 2021.
Financial Results for the Fourth
Quarter of 2021 (IFRS):
Total revenues for the fourth quarter of 2021 were € 52.9
million compared to € 36.0 million for the same period in 2020.
in € million
Q4 2021
Q3 2021
Q4 2020
Q-Q Δ
Y-Y Δ
Total revenues
52.9
41.2
36.0
28%
47%
Monjuvi product sales
20.5
18.6
14.1
10%
45%
Royalties
23.2
17.0
12.1
36%
92%
Licenses, milestones and
other
9.3
5.6
9.8
66%
(5)%
Cost of Sales: In the fourth quarter of 2021, cost of
sales was € 9.5 million compared to € 9.4 million for the
comparable period in 2020.
Research and Development (R&D) Expenses: In the
fourth quarter of 2021, R&D expenses were € 87.0 million (Q4
2020: € 52.8 million). The increase in R&D expenses is
primarily due to the inclusion of R&D expenses from
Constellation and higher investment to support the advancement of
clinical programs.
Selling, General and Administrative (SG&A) Expenses:
Selling expenses decreased in the fourth quarter of 2021 to € 32.5
million (Q4 2020: € 32.8 million) and general and administrative
(G&A) expenses amounted to € 18.2 million (Q4 2020: € 14.2
million). The increase in G&A expense in the fourth quarter was
driven mainly by transaction costs for the acquisition of
Constellation and the inclusion of Constellation’s G&A
expenses.
Impairment of Goodwill: In the fourth quarter, MorphoSys
accounted for a non-cash impairment charge on goodwill in the
amount of € 230.7 million, due to the decision to discontinue all
US-based drug discovery and biology activities of Constellation
which MorphoSys acquired in July 2021. MorphoSys will continue to
focus its research activities on the most advanced programs at its
German research hub in Planegg.
Operating Loss: Operating loss amounted to € 325.0
million in the fourth quarter of 2021 (Q4 2020: operating loss of €
75.2 million).
Consolidated Net Profit / Loss: For the fourth quarter of
2021, consolidated net loss was € 381.0 million (Q4 2020:
consolidated net loss of € 16.5 million).
Financial Results for the Full Year
2021 (IFRS):
Total revenues for the full year of 2021 were € 179.6
million compared to € 327.7 million in 2020. The year-over-year
decline was driven by the upfront payment of the collaboration and
license agreement with Incyte executed in 2020 for the
out-licensing of tafasitamab outside the U.S. The Group revenues
include revenues of € 66.9 million from the recognition of Monjuvi
product sales in the US. Royalties in 2021 included € 0.7 million
from the sale of Minjuvi outside of the U.S. by our partner Incyte
and € 64.9 million from Tremfya sales. While Tremfya royalties will
continue to be recorded on MorphoSys’ income statement, the
payments for these royalties are passed onto Royalty Pharma
starting in the second quarter of 2021. As such, € 53.4 million of
Tremfya royalties were passed on to Royalty Pharma in 2021.
in € million*
2021
2020
Y-Y Δ
Total revenues
179.6
327.7
(45)%
Product sales
66.9
18.5
>100%
Royalties
65.6
42.5
54%
Licenses, milestones and other
47.2
266.7
(82)%
* Differences due to rounding.
Cost of Sales: For full year 2021, cost of sales were €
32.2 million compared to € 9.2 million in 2020. The year-over-year
increase was primarily driven by higher sales of Monjuvi in the
U.S.
R&D Expenses: In 2021, R&D expenses were € 225.2
million compared to € 139.4 million in 2020. The R&D expenses
increased due to higher development activity and the inclusion of
expenses from the Constellation acquisition since July 15,
2021.
SG&A Expenses: Selling expenses increased in 2021 to
€ 121.5 million compared to € 107.7 million in 2020. The
year-over-year increase was primarily driven by the first full year
of commercialization activities for Monjuvi compared to the ramp up
of activities in 2020.
G&A expenses amounted to € 78.3 million compared to € 51.4
million in 2020. The year-over-year increase was driven primarily
by the transaction-related costs of € 37.3 million related to the
Constellation and Royalty Pharma agreements. In addition,
Constellation’s G&A expenses were included for the first
time.
Operating Loss: Operating loss amounted to € 508.3
million in 2021 compared to an operating profit of € 18.0 million
in 2020.
Consolidated Net Profit / Loss: For the full year of
2021, consolidated net loss was € 514.5 million compared to a net
profit of € 97.9 million in 2020.
Cash and Other Financial Assets: As of December 31, 2021,
the Company had cash and other financial assets of € 976.9 million
compared to € 1,244.0 million on December 31, 2020.
Number of shares: The number of shares issued totaled
34,231,943 on December 31, 2021 compared to 32,890,046 at the end
of 2020.
Full Year 2022 Financial
Guidance:
Amounts in million
2022 Financial
Guidance
2022 Guidance Insights
Monjuvi U.S. Net Product
Sales
US$ 110m to 135m
100% of Monjuvi U.S. product
sales are recorded on MorphoSys’ income statement and related
profit/loss is split 50/50 between MorphoSys and Incyte.
Gross Margin for Monjuvi U.S. Net
Product Sales
75% to 80%
100% of Monjuvi U.S. product cost
of sales is recorded on MorphoSys’ income statement and related
profit/loss is split 50/50 between MorphoSys and Incyte.
R&D expenses
€ 300m to 325m
2022 growth over 2021 will be
driven primarily by investment in ongoing pivotal phase-3 studies,
excluding transaction/restructuring/other charges related to
Constellation acquisition recorded in 2021.
SG&A expenses
€ 155m to 170
51% to 56% of mid-point of
SG&A expenses represents Monjuvi U.S. selling costs of which
100% are recorded in MorphoSys’ income statement. Incyte reimburses
MorphoSys for half of these selling expenses.
For 2022, we anticipate a
year-over-year decline in SG&A, excluding
transaction/restructuring/other charges related to Constellation
acquisition recorded in 2021.
Additional information related to 2022 Financial Guidance:
- Tremfya royalties will continue to be recorded as revenue
without any cost of sales in MorphoSys’ income statement. These
royalties, however, will not contribute any cash to MorphoSys as
100% of the royalties will be passed on to Royalty Pharma.
- MorphoSys anticipates receiving royalties for Minjuvi sales
outside of the U.S. Guidance for these royalties is not being
provided as MorphoSys does not receive any sales forecasts from its
partner Incyte.
- MorphoSys does not anticipate any significant cash-accretive
revenues from the achievement of milestones in 2022. Milestones for
otilimab are passed on to Royalty Pharma. Milestones from all other
programs remain with MorphoSys at 100%.
- MorphoSys anticipates sales of commercial and clinical supply
of tafasitamab outside of the U.S. to its partner Incyte. Revenue
from this supply is recorded in the “Licenses, milestones and
other” category in MorphoSys’ income statement. These sales result
in a zero gross profit/margin. As such, MorphoSys does not provide
guidance for these sales.
- While R&D expense is anticipated to grow year-over-year due
to investments in three pivotal studies, the growth is partially
being offset by the consolidation of research/discovery
activities.
- SG&A expense guidance range reflects savings from synergies
following the acquisition of Constellation and streamlined
commercialization efforts.
- Anticipated foreign exchange (USD/EUR) to impact operating
expenses (R&D and SG&A) negatively by approximately
3%.
***
Operational Outlook for
2022:
MorphoSys anticipates the following key development milestones
in 2022:
- First proof-of-concept data from the ongoing clinical phase 2
study of CPI-0209 in solid tumors and blood cancer;
- Additional data from the phase 1/2 M-PLACE (proof-of-concept)
study of felzartamab for the treatment of anti-PLA2R antibody
positive membranous nephropathy (MN);
- First data from the phase 2 study (IGNAZ) to evaluate
felzartamab in patients with immunoglobulin A nephropathy
(IgAN);
- MorphoSys’ partner Roche expects a pivotal data readout of the
GRADUATE 1 and GRADUATE 2 trials with gantenerumab in the second
half of 2022. Roche initiated these phase 3 development program for
patients with Alzheimer’s disease in 2018;
- Initiation of a combination study (in collaboration with Incyte
and Xencor) of tafasitamab, plamotamab and lenalidomide in patients
with relapsed or refractory diffuse large B-cell lymphoma (DLBCL),
first-line DLBCL and relapsed or refractory follicular lymphoma
(FL).
MorphoSys Group Key Figures (IFRS, end
of financial year: December 31, 2021)
in € million
2021
2020
Δ
Q4 2021
Q4 2020
Δ
Revenues
179.6
327.7
(45)%
52.9
36.0
47%
Product Sales
66.9
18.5
>100%
20.5
14.1
45%
Royalties
65.6
42.5
54%
23.2
12.1
91%
Licenses, milestones and other
47.2
266.7
(82)%
9.3
9.8
(5)%
Cost of Sales
(32.2)
(9.2)
251%
(9.5)
(9.4)
1%
Gross Profit
147.4
318.5
(54)%
43.4
26.6
63%
Total Operating Expenses
(655.8)
(300.6)
>100%
(368.4)
(101.8)
>100%
Research and Development
(225.2)
(139.4)
62%
(87.0)
(52.8)
65%
Selling
(121.5)
(107.7)
13%
(32.5)
(32.8)
(1)%
General and Administrative
(78.3)
(51.4)
52%
(18.2)
(14.2)
28%
Impairment of Goodwill
(230.7)
(2.1)
>100%
(230.7)
(2.1)
>100%
Operating Profit / (Loss)
(508.3)
18.0
>(100)%
(325.0)
(75.2)
>100%
Other Income
8.2
14.6
(44)%
3.4
2.9
15%
Other Expenses
(6.4)
(5.2)
23%
(1.7)
(2.2)
(22)%
Finance Income
96.6
92.0
5%
(2.7)
31.6
>(100)%
Finance Expenses
(181.5)
(96.2)
89%
(89.0)
5.7
>(100)%
Income from Reversals of Impairment
0.3
(0.7)
>100%
(0.2)
0.4
>(100)%
Income Tax Benefit / (Expenses)
76.6
75.4
2%
34.4
20.2
70%
Consolidated Net Profit / (Loss)
(514.5)
97.9
>(100)%
(381.0)
(16.5)
>100%
Earnings per Share, Basic and Diluted
(15.40)
—
—
(11.16)
(0.50)
>100%
Earnings per Share, Basic
—
3.01
—
—
—
—
Earnings per Share, diluted
—
2.97
—
—
—
—
Cash and other financial assets (end of
period)
976.9
1,244.0
(21)%
976.9
1,244.0
(21)%
MorphoSys will hold its conference call and webcast tomorrow,
March 17, 2022, to present the full year 2021 results the outlook
for 2022.
Dial-in number for the conference call (in English) at 1:00pm
CET; 12:00pm GMT; 8:00am EDT:
Germany:
+49 69 201 744 220
For UK residents:
+44 203 009 2470
For US residents:
+1 877 423 0830
(All numbers reachable from any
geography)
Participant PIN:
41714570#
Please dial in 10 minutes before the beginning of the
conference.
A live webcast and slides will be made available at the
Investors section under "Upcoming Events & Conferences" on
MorphoSys' website, http://www.morphosys.com and after the call, a
slide-synchronized audio replay of the conference will be available
at the same location.
Consolidated Financial Statements 2021 (IFRS) are available for
download at:
https://www.morphosys.com/en/investors/financial-information
About MorphoSys
At MorphoSys, we are driven by our mission to give more life for
people with cancer. As a global commercial-stage biopharmaceutical
company, we use groundbreaking science and technologies to
discover, develop, and deliver innovative cancer medicines to
patients. MorphoSys is headquartered in Planegg, Germany, and has
its U.S. operations anchored in Boston, Massachusetts. To learn
more, visit us at www.morphosys.com and follow us on Twitter and
LinkedIn.
About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting
monoclonal antibody. In 2010, MorphoSys licensed exclusive
worldwide rights to develop and commercialize tafasitamab from
Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc
domain, which mediates B-cell lysis through apoptosis and immune
effector mechanism including Antibody-Dependent Cell-Mediated
Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis
(ADCP).
In the United States, Monjuvi® (tafasitamab-cxix) is approved by
the U.S. Food and Drug Administration in combination with
lenalidomide for the treatment of adult patients with relapsed or
refractory DLBCL not otherwise specified, including DLBCL arising
from low grade lymphoma, and who are not eligible for autologous
stem cell transplant (ASCT). This indication is approved under
accelerated approval based on overall response rate. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional marketing
authorization in combination with lenalidomide, followed by Minjuvi
monotherapy, for the treatment of adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) who are not
eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials.
Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG.
Tafasitamab is co-marketed by Incyte and MorphoSys under the brand
name Monjuvi® in the U.S., and marketed by Incyte under the brand
name Minjuvi® in the EU.
XmAb® is a registered trademark of Xencor, Inc.
Forward Looking Statements
This communication contains certain forward-looking statements
concerning the MorphoSys group of companies. The forward-looking
statements contained herein represent the judgment of MorphoSys as
of the date of this release and involve known and unknown risks and
uncertainties, which might cause the actual results, financial
condition and liquidity, performance or achievements of MorphoSys,
or industry results, to be materially different from any historic
or future results, financial conditions and liquidity, performance
or achievements expressed or implied by such forward-looking
statements. In addition, even if MorphoSys' results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are that MorphoSys' expectations may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements, MorphoSys' reliance on
collaborations with third parties, estimating the commercial
potential of its development programs and other risks indicated in
the risk factors included in MorphoSys' Annual Report on Form 20-F
and other filings with the U.S. Securities and Exchange Commission.
Given these uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
of this document. MorphoSys expressly disclaims any obligation to
update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or regulation.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220316005979/en/
Media Contacts: Thomas Biegi Vice President Tel.: +49
(0)89 / 899 27 26079 thomas.biegi@morphosys.com
Jeanette Bressi Director, US Communications Tel: +1 617 404 7816
jeanette.bressi@morphosys.com
Investor Contacts: Dr. Julia Neugebauer Senior Director
Tel: +49 (0)89 / 899 27 179 julia.neugebauer@morphosys.com
Myles Clouston Senior Director Tel: +1 857 772 0240
myles.clouston@morphosys.com
MorphoSys (NASDAQ:MOR)
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